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Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firebird 2 stent group | Experimental | the patients who receive Firebird 2 stent |
|
| Excel stent group | Active Comparator | the patients who receive Excel stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firebird 2 sirolimus-eluting stent | Device | the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late lumen loss at 9 months' angiographic follow-up | patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| target vessel failure | defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]). | 2 years after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17442198 | Background | Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8. | |
| 18655114 |
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| Excel sirolimus-eluting stent | Device | the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform |
|
| Background |
| Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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